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A
Affolter, Stephan
Ypsomed AG
International Regulatory Changes: Member States - Deal or No Deal: The Impact of the MRA Switzerland – EU on Medtech in Europe
Stephan Affolter
Favorite
Akra, Bassil
QUNIQUE GmbH
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Bassil Akra
Favorite
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Bassil Akra
Favorite
Arnold-Round, Jane
Combination Products
Jane Arnold-Round
Favorite
MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!
Jane Arnold-Round
Favorite
Arora, Deepa
Clinexel Life Sciences Private Limited
Working with FDA: Factors for Successful Approval
Deepa Arora
Favorite
Arora, Sharry
COVID-19: Implications for the Future of Regulatory
Sharry Arora
Favorite
B
Baird, Pat
Philips
Software as a Medical Device: Comparison Between US and EU Approaches
Pat Baird
Favorite
Baldwin, Hilary
Caris Life Sciences
Implementing Practices to Comply with the In Vitro Diagnostics Regulation
Hilary Baldwin
Favorite
Navigating the Pre-Market Approval Process for FDA
Hilary Baldwin
Favorite
Bannick McQuoid, Karen
Bannick LLC
Clinical Evaluation Reports (CERs)
Karen Bannick McQuoid
Favorite
Bassett, Richard
NAMSA
Risk Management - Focal Point for Regulatory and Legal Purposes
Richard Bassett
Favorite
Bertoli, Maria Mercedes
Self-employee
Orphan Drugs: Challenges and Differences for its Designation in the European Union and the United States of America
Maria Mercedes Bertoli
Favorite
Beuzeval, Rod
Meddev Solutions
Meet the Authors: European In Vitro Diagnostic Regulation Guidebook
Rod Beuzeval
Favorite
Meet the Authors: European Medical Device Regulation Guidebook
Rod Beuzeval
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Bos, Gert
Qserve Group (Netherlands)
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
Gert Bos
Favorite
Fireside Debate with IVDR Notified Body and Industry Representation
Gert Bos
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Gert Bos
Favorite
Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Gert Bos
Favorite
Bowness, Peter
British Standards Institution
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Peter Bowness
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Buchner, Leonard
Qserve Group
Vigilance and Trend Reporting
Leonard Buchner
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Budashewitz, Philip
U.S. Food and Drug Administration
Working with FDA - Form FDA 1572 (Statement of Investigator) Signature Waivers at Non-US Sites
Philip Budashewitz
Favorite
Bundalo, Dragana
PharmaSwiss
Live Q&A: poster presentations 1 - 3
Dragana Bundalo
Favorite
Poster Presentation 2: Regulatory Challenges in the Non-EU Countries of the SEE Region
Dragana Bundalo
Favorite
C
Celis, Patrick
European Medicines Agency
Regulatory Strategy for Gene Therapy: Challenges and Opportunities
Patrick Celis
Favorite
Chaillou, Marc
Schlafender Hase GmbH
The Leading Global Solution For All Your Proofreading Tasks (Sponsored by: Schlafender Hase GmbH)
Marc Chaillou
Favorite
Cobbaert, Koen
Philips
Software as a Medical Device
Koen Cobbaert
Favorite
Conway, Erica
BSI (London)
In Vitro Diagnostics Regulation (IVDR)
Erica Conway
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Erica Conway
Favorite
Cordie-Bancroft, Lena
Qualitas Professional Services, LLC
Developing a Global Unique Device Identification (UDI) Program
Lena Cordie-Bancroft
Favorite
Innovators and Regulators: Time to Collaborate
Lena Cordie-Bancroft
Favorite
International Regulatory Landscape Changes: Asia & ASEAN Effective Regulatory Strategy & Update in MedTech Product Registration Process
Lena Cordie-Bancroft
Favorite
Regulatory Landscape for Medial Device In China
Lena Cordie-Bancroft
Favorite
UDI/Labeling
Lena Cordie-Bancroft
Favorite
Cuper, Natascha
DARE Medical Certifications
Clinical Evaluation: Clinical Data Versus Non-clinical Data; How to Interpret Article 61.10
Natascha Cuper
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Natascha Cuper
Favorite
D
de Bruin, Martin
Hot RA/QA/Clinical Topics (Sponsored by: Qserve)
Martin de Bruin
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Delpozo, Angel
BioKeralty Research Institute
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
Angel Delpozo
Favorite
Di Cioccio, Mark
Team Consulting
Working with FDA - Form FDA 1572 (Statement of Investigator) Signature Waivers at Non-US Sites
Mark Di Cioccio
Favorite
Working with FDA - How to Prepare a Well-received IND
Mark Di Cioccio
Favorite
Di Rienzo, Giovanni
Qserve Consultancy
Clinical Evaluation Reports (CERs)
Giovanni Di Rienzo
Favorite
Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Giovanni Di Rienzo
Favorite
Dollins, Claudia
Merck Healthcare KGaA
In Vitro Diagnostics Regulation (IVDR)
Claudia Dollins
Favorite
Donawa, Maria
Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies
Maria Donawa
Favorite
E
Eglem, Steve
AFMPH (Competent Authority of Belgium)
Clinical Investigation under MDR
Steve Eglem
Favorite
F
Farley, Tim
Medidee Services SA
Give Me Data: Challenges and Opportunities of Real-World Evidence
Tim Farley
Favorite
Faßhauer, Stefanie
PharmaLex
Changing Pharmaceutical Regulatory Landscape in China and Asia - The Dynamics and Outlook of the ASEAN Regulatory Landscape
Stefanie Faßhauer
Favorite
G
Gfoeller, Elizabeth
Med-El
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Elizabeth Gfoeller
Favorite
H
Hansen, Joyce
Johnson & Johnson
Innovators and Regulators: Time to Collaborate
Joyce Hansen
Favorite
Hansson, Erik
DG for Health and Food Safety (SANTE)
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Erik Hansson
Favorite
Hernandez, Monica
Cardinal Health
Live Q&A: poster presentations 4 - 5
Monica Hernandez
Favorite
Poster Presentation 5: Can Legislation Evolve Along with Technology? Case Study: Software as Medical Device in Emerging Markets
Monica Hernandez
Favorite
Herzog, Dominik
TentaMedix GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Dominik Herzog
Favorite
Hidalgo-Simon, Ana
European Medicines Agency
RNA-Based Therapeutics: Opportunities and Challenges
Ana Hidalgo-Simon
Favorite
Hoekstra-van den Bosch, Sabina
TUV SUD Product Service GmbH
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
Sabina Hoekstra-van den Bosch
Favorite
Clinical Investigation under MDR
Sabina Hoekstra-van den Bosch
Favorite
Clinical Studies in PMCF
Sabina Hoekstra-van den Bosch
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Sabina Hoekstra-van den Bosch
Favorite
Hohenbrink, Philipp
Medical Device Safety Service GmbH
In Vitro Diagnostics Regulation (IVDR)
Philipp Hohenbrink
Favorite
Hovestadt, Leo
Elekta
Software as a Medical Device
Leo Hovestadt
Favorite
Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Leo Hovestadt
Favorite
Humphreys, Anthony
European Medicines Agency
Supporting Innovation
Anthony Humphreys
Favorite
J
Johner, Christian
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Christian Johner
Favorite
K
Karrer, Daniela
Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies
Daniela Karrer
Favorite
Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation
Daniela Karrer
Favorite
Katta, Jayanth
BSI
Combination Products
Jayanth Katta
Favorite
MDR: Lessons Learned
Jayanth Katta
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Jayanth Katta
Favorite
Keene, Adrian
NAMSA
Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation
Adrian Keene
Favorite
Kennedy, Rachel
LabCorp.
Performance Evaluation Reports - Planning and Preparation in Anticipation of IVDR Requirements
Rachel Kennedy
Favorite
Klasen, Eric
Founder of Waypoint Consulting
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Eric Klasen
Favorite
Klein, John
NorthCoast Clinical Consulting, LLC
Navigating the Future of Regulatory Affairs - The Future of the Regulatory Affairs Profession
John Klein
Favorite
Klompmaker, Sandra
Medidee Services
Give Me Data: Challenges and Opportunities of Real-World Evidence
Sandra Klompmaker
Favorite
Kresankova, Katarina
Schlafender Hase GmbH
The Leading Global Solution For All Your Proofreading Tasks (Sponsored by: Schlafender Hase GmbH)
Katarina Kresankova
Favorite
Krzeszak, Jason
NAMSA
Working with FDA: Factors for Successful Approval
Jason Krzeszak
Favorite
Kuhn, Andreas
BioNTech RNA Pharmaceuticals GmbH
RNA-Based Therapeutics: Opportunities and Challenges
Andreas Kuhn
Favorite
L
Laan, Alex
NAMSA
Challenges and Understanding of the Periodic Safety Update Report (PSUR)
Alex Laan
Favorite
Lanigan, Mark
World Health Organization
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
Mark Lanigan
Favorite
Larsson, Kristina
European Medicines Agency
Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs
Kristina Larsson
Favorite
Lassoff, Peter
Syneos Health
Navigating the Future of Regulatory Affairs - Getting Out More - How Regulatory Affairs Professionals Can Connect with the Shop Floor
Peter Lassoff
Favorite
Navigating the Future of Regulatory Affairs - The Future of the Regulatory Affairs Profession
Peter Lassoff
Favorite
Lim, Joalin
Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
International Regulatory Landscape Changes: Asia & ASEAN Effective Regulatory Strategy & Update in MedTech Product Registration Process
Joalin Lim
Favorite
Lindner, Christoph
TUV Sud Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Christoph Lindner
Favorite
Liu, Yingying
CSL Behring
Changing Pharmaceutical Regulatory Landscape in China and Asia
Yingying Liu
Favorite
Regulatory Landscape for Medial Device In China
Yingying Liu
Favorite
Lockwood, John
Pearl Pathways
Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions
John Lockwood
Favorite
Louati, Claudia
US Food and Drug Administration, Europe Office
Regulatory Changes: Biosimilars
Claudia Louati
Favorite
M
Maier, Michael
Medidee Services SA
Give Me Data: Challenges and Opportunities of Real-World Evidence
Michael Maier
Favorite
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
Michael Maier
Favorite
Marjan, Dzeparoski
Bionika Pharmaceuticals
Poster Presentation 3: eSubmissions: Regional Moving Towards Global Aspects
Dzeparoski Marjan
Favorite
Live Q&A: poster presentations 1 - 3
Dzeparoski Marjan
Favorite
Marton, Gabriela
Arriello s.r.o
Regulatory Changes: Biosimilars
Gabriela Marton
Favorite
Maxwell, Amanda
Medtech Insight
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
Amanda Maxwell
Favorite
McDermott, Olivia
Olivia McDermott Hayes
Live Q&A: poster presentations 4 - 5
Olivia McDermott
Favorite
Poster Presentation 4: The Importance of a Regulatory Qualification and Continuous Professional Development in Career Progression and Advancement
Olivia McDermott
Favorite
Meffen, MS, CQA, Tracy
Genevant Sciences
RNA-Based Therapeutics: Opportunities and Challenges
Tracy Meffen, MS, CQA
Favorite
Meurant, Robyn
NSF International
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
Robyn Meurant
Favorite
Milobratovic, Irena
Arriello
Regulatory Changes: Biosimilars
Irena Milobratovic
Favorite
Moeller, Ludger
Medical Device Safety Service GmbH
MDR Implementation: Economic Operator Requirements
Ludger Moeller
Favorite
Morel, Keith
Qserve Group Inc. - ENTERPRISE
Vigilance and Trend Reporting
Keith Morel
Favorite
Mortazavi, Charlie
SANOFI
Live Q&A: poster presentations 1 - 3
Charlie Mortazavi
Favorite
Live Q&A: poster presentations 4 - 5
Charlie Mortazavi
Favorite
MA Lifecycle Management - The Trials and Tribulations of Handling Older Regulatory Applications
Charlie Mortazavi
Favorite
MA Lifecycle Management - Towards an Agile Risk-based Variation Regulatory Framework
Charlie Mortazavi
Favorite
Mosso, Matteo
Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies
Matteo Mosso
Favorite
N
Ndefo, Yvonne
NSAI
Clinical Studies in PMCF
Yvonne Ndefo
Favorite
Neff, Jennifer
bess AG
Orphan Drugs: Challenges and Differences for its Designation in the European Union and the United States of America
Jennifer Neff
Favorite
Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs
Jennifer Neff
Favorite
Regulatory Changes: Biosimilars
Jennifer Neff
Favorite
Nogueira, Diana
Qserve Group Deutschland GmbH
Clinical Evaluation Reports (CERs)
Diana Nogueira
Favorite
Nuebling, Micha
Paul-Ehrlich-Institut
In Vitro Diagnostics Regulation (IVDR)
Micha Nuebling
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Micha Nuebling
Favorite
O
Omokaro, Stephanie
U.S. Food & Drug Administration
COVID-19: Implications for the Future of Regulatory
Stephanie Omokaro
Favorite
Supporting Innovation
Stephanie Omokaro
Favorite
P
Padovani, Rima
Medidee Services SA
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
Rima Padovani
Favorite
Pankhurst, Quentin
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
Quentin Pankhurst
Favorite
Patten, Tom
NSAI
Fireside Debate with IVDR Notified Body and Industry Representation
Tom Patten
Favorite
Piriou, Camille
BlueReg
From Product Information to Promotional Material - Promotional Material and National Regulations in EU: How to Successfully Launch Your Product in Different Markets?
Camille Piriou
Favorite
Postma, Wiebe
Qserve Group B.V.
Clinical Investigation under MDR
Wiebe Postma
Favorite
Clinical Studies in PMCF
Wiebe Postma
Favorite
Pradhan, Reeshav
Technical University of Applied Science Luebeck
Live Q&A: poster presentations 1 - 3
Reeshav Pradhan
Favorite
Prins, Menno
Eindhoven University of Technology
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
Menno Prins
Favorite
Purde, Andreas
TÜV SÜD Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Andreas Purde
Favorite
R
Raadsheer, Erik
Align Technology, BV.
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Erik Raadsheer
Favorite
Rad, Abtin
- SaMD/Cybersecurity - Regulatory Strategies for Machine Learning/AI and Software as a Medical Device (SaMD)
Abtin Rad
Favorite
Reynolds, Chad
Maetrics
MDR Implementation: Economic Operator Requirements
Chad Reynolds
Favorite
Richards, Simon
Abbott Rapid Diagnostics
Fireside Debate with IVDR Notified Body and Industry Representation
Simon Richards
Favorite
In Vitro Diagnostics Regulation (IVDR)
Simon Richards
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Simon Richards
Favorite
Ritzhaupt, Armin
European Medicines Agency
Combination Products
Armin Ritzhaupt
Favorite
Fireside Debate with IVDR Notified Body and Industry Representation
Armin Ritzhaupt
Favorite
Implementing Practices to Comply with the In Vitro Diagnostics Regulation
Armin Ritzhaupt
Favorite
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Armin Ritzhaupt
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Royle, Matt
NAMSA
Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload
Matt Royle
Favorite
S
Satyal, Umesh
Lübeck University of Applied Science, Lübeck, Germany
Live Q&A: poster presentations 1 - 3
Umesh Satyal
Favorite
Scanlan, Elizabeth
European Medicines Agency
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe
Elizabeth Scanlan
Favorite
Schmitt, Siegfried
Parexel
Dealing with Regulatory Requirements - Regulatory Challenges Faced Successfully Taking a New Client out of MHRA Compliance Management Team (CMT) Measures (Data Integrity Issues)
Siegfried Schmitt
Favorite
Navigating the Future of Regulatory Affairs - Getting Out More - How Regulatory Affairs Professionals Can Connect with the Shop Floor
Siegfried Schmitt
Favorite
Supporting Innovation
Siegfried Schmitt
Favorite
Seevers, Robert
Pearl Pathways
Working with FDA - How to Prepare a Well-received IND
Robert Seevers
Favorite
Seibl, Reinhart
UDI/Labeling
Reinhart Seibl
Favorite
Senac, Julien
Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Julien Senac
Favorite
Shortt, Colette
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe
Colette Shortt
Favorite
From Product Information to Promotional Material - Promotional Material and National Regulations in EU: How to Successfully Launch Your Product in Different Markets?
Colette Shortt
Favorite
Shrestha, Shristi
Lübeck University of Applied Sciences
Live Q&A: poster presentations 1 - 3
Shristi Shrestha
Favorite
Poster Presentation 1: Development of a Digital Tool for Risk Management, Post-Market Surveillance, Clinical Evaluation of Medical Devices
Shristi Shrestha
Favorite
Shukla, Mridula
Arcutis Biotherapeutics Inc.
Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs
Mridula Shukla
Favorite
Regulatory Strategy for Gene Therapy: Challenges and Opportunities
Mridula Shukla
Favorite
Slisz, Mark
Pearl Pathways
MA Lifecycle Management - The Trials and Tribulations of Handling Older Regulatory Applications
Mark Slisz
Favorite
Spencer, Sue
Qserve Group (United Kingdom)
Fireside Debate with IVDR Notified Body and Industry Representation
Sue Spencer
Favorite
Sproho, Thomas
Chubb
MDR Implementation: Economic Operator Requirements
Thomas Sproho
Favorite
Stange, Andreas
TÜV SÜD Japan
Fireside Debate with IVDR Notified Body and Industry Representation
Andreas Stange
Favorite
Strobel, Hans
dokspot GmbH, Zurich, Switzerland
UDI/Labeling
Hans Strobel
Favorite
Sutch, Jonathan
BSI
Combination Products
Jonathan Sutch
Favorite
Sweeney, Fergus
COVID-19: Implications for the Future of Regulatory
Fergus Sweeney
Favorite
T
Tabutin, Sophie
W.L. Gore & Associates
MDR: Lessons Learned
Sophie Tabutin
Favorite
Thompson, David
Clarity compliance solutions ltd
Dealing with Regulatory Requirements - Regulatory Challenges Faced Successfully Taking a New Client out of MHRA Compliance Management Team (CMT) Measures (Data Integrity Issues)
David Thompson
Favorite
Torqui, Aimad
MSD
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe
Aimad Torqui
Favorite
Trautman, Kimberly
Risk Management - Focal Point for Regulatory and Legal Purposes
Kimberly Trautman
Favorite
Trivedi, Pallavi
Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Changing Pharmaceutical Regulatory Landscape in China and Asia
Pallavi Trivedi
Favorite
Changing Pharmaceutical Regulatory Landscape in China and Asia - The Dynamics and Outlook of the ASEAN Regulatory Landscape
Pallavi Trivedi
Favorite
COVID-19: Implications for the Future of Regulatory
Pallavi Trivedi
Favorite
V
van Boxtel, Robert
Medical Device Project B.V.
Clinical Evaluation: Clinical Data Versus Non-clinical Data; How to Interpret Article 61.10
Robert van Boxtel
Favorite
van Dongen, Jacques
Leiden University Medical Center (LUMC)
IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs
Jacques van Dongen
Favorite
Van Hove, Luc
MARACA International bvba
Implementing Practices to Comply with the In Vitro Diagnostics Regulation
Luc Van Hove
Favorite
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
Luc Van Hove
Favorite
What is Sufficient Clinical Evidence for IVDs in Preparation for the IVDR?
Luc Van Hove
Favorite
Van Hoven, John
Rocky Mountain Regulatory and Quality Partners
Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions
John Van Hoven
Favorite
van Loon, Jan-Paul
Qserve Consultancy BV
MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!
Jan-Paul van Loon
Favorite
Van Nerom, Anne
Sciensano
European Union Reference Laboratory for IVD
Anne Van Nerom
Favorite
Voelksen, Rainer
VOELKSEN Regulatory Affairs
International Regulatory Changes: Member States - Legal Structure Changes: Pharma, Biotech and Medical Devices Back in DG Health; New German Law (BfArM Receiving Executive Power)
Rainer Voelksen
Favorite
Vollebregt, Erik
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
Erik Vollebregt
Favorite
MDR Implementation: Economic Operator Requirements
Erik Vollebregt
Favorite
W
Waesch, Susana
Ypsomed
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Susana Waesch
Favorite
Walker, Melissa
Graematter, Inc.
Working with FDA: Factors for Successful Approval
Melissa Walker
Favorite
Weijers, Waldo
Medicines Evaluation Board (NL)
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Waldo Weijers
Favorite
Wiersma, Anja
mi-CE consultancy
In Vitro Diagnostics Regulation (IVDR)
Anja Wiersma
Favorite
IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs
Anja Wiersma
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Witte, Martin
TÜV SÜD Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements
Martin Witte
Favorite
Z
Ziel, Klaus-Dieter
MEDCERT GmbH, Notified Body Germany
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape
Klaus-Dieter Ziel
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